I-COPE Study: Opioid Use and Pain Management in Older Adults (I-COPE)

January 18, 2024 updated by: University of Chicago

Improving Chicago Older Adult Opioid and Pain Management Through Patient-Centered Clinical Decision Support and Project ECHO

Adults over 65 years of age are at higher risk of experiencing chronic pain and adverse events from opioids and opioid use disorder (OUD). Older adults are more likely to inadequately report their pain due to age-related health, which may lead to undertreatment of pain. In the last two decades, opioid prescriptions to treat chronic pain among older adults increased at a rate of nine times what it was previously. This surge is accompanied with a drastic increase of older adults visiting emergency departments due to opioid abuse, misuse, overdose, and addictions to heroin and cocaine. In consequence, chronic pain, opioids, and OUD have become a major crisis in the United States among older adults. The I-COPE program is an intervention that offers providers a set of smart tools for a more effective and efficient geriatric pain, opioid, and OUD management. The aim of the I-COPE program is to evaluate integration of shared decision-making, patient-centered clinical decision support tools, and Project ECHO® to address the critical need to integrate effective treatment for older adults with chronic pain, opioid use, and OUD. Patient-centered clinical decision support (PCCDS) tools provide clinicians with information presented at the right time and tailored to the individual patient, improving communications, care, and patient-provider satisfaction. Shared decision making (SDM) is a highly effective collaborative framework when there are many choices and there is uncertainty about the optimal treatment choice. Project ECHO® is a tested model for delivery of subspecialized medical knowledge to community clinicians. The research into these strategies is supported by the Agency for Healthcare Research and Quality (AHRQ) through the opioid action plan (OAP) initiative. Based on the survey responses the PCCDS will develop a list of pain treatments that are preferable for older adults to use, based on their individual histories. From the PCCDS, an individualized patient action plan will be generated. The action plan will be clearly laid out, use patient-centered language at an ≤ 6th grade level, and simple graphics. It will feature the patient-reported overall goal, current pain rating and pain goal, as well as provide information on changes made to the chronic pain treatment plan. Information about signs of opioid side effects, misuse and opioid overdoses will be included for patients who are taking opioids, as well as instructions for naloxone administration.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

I-COPE program intervention includes four components: patient survey, geriatric PCCDS tool, patient action plan, and provider education.

Patient survey. Three days before each of their scheduled PCP visits, patients will be asked to complete a survey during electronic check-in. If patients have not completed the questionnaire when they arrive on the day of their appointment, they will be asked by the patient services representatives to complete it in the waiting area on paper or using a tablet, or by the medical assistant to complete it during patient triage. In addition to the I-COPE survey patients will be screened for depression and drug abuse. Medical assistants will be trained to enter their responses into the EHR. A caregiver may help the patient complete the questionnaire. Responses will be saved in the patient's medical record and accessible to their care team.

Geriatric PCCDS tool. Information from the patient questionnaire and the EHR will be used to automatically generate a passive alert (best practice advisory) and a tailored smart set which PCPs can open during the visit. The alert will be triggered if a patient responds that they want to discuss pain at their visit or if they screen positive for a possible substance use disorder. The PCCDS was designed with a set of decision rules based on AGS and CDC guidelines for chronic pain and opioids. The PCCDS tool features five sections: All patients (self-management strategies), Oral non-opioid medications, Acute-on-chronic pain only, Opioid medications, and OUD treatment. The PCCDS shows which treatment options are recommended, not recommended, or contraindicated based on the patient's history, comorbidities, and preferences. For instance, if a patient screens positive for depression the Antidepressants smartgroup within the Oral non-opioid medications section will be open and labelled as recommended. Alternative versions of other smartgroups exist for patients with chronic kidney disease of various stages, presence of certain medication, and results of the drug abuse screening. The PCCDS tool also includes links to a conversation tool and patient self-management education tools. The PCCDS tool may be accessed by a provider in cases where patient did not complete the survey.

Patient action plan. At the end of the visit, a personalized action plan will be generated for patients featuring their pain rating and goal, the treatment plan they agreed upon with their PCP, and relevant educational materials. The action plan will be clearly laid out using patient-centered language, maximum 6th grade reading level, and simple graphics. It will be printed out as a part of the after-visit summary.

Provider education. PCPs may opt into an intensive Project ECHO course that offers more geriatric clinical content and EHR updates with real-word cases. Project ECHO (Extension for Community Health Outcomes) is an innovative workforce development model for expanding primary care capacity in underserved communities. It uses videoconferencing technology to "telementor" community-based clinicians via didactic education, group problem solving with actual cases brought by clinicians, and expert advice on implementing best practices. Project ECHO® is possibly a cost-effective strategy for improving clinician competence and behaviors, while likely improving patient outcomes. The curriculum will be delivered in 8-weekly hour-long sessions. Each session will include didactic topics delivered by an interdisciplinary team of content experts, and two 15-minute problem-solving exercises using real-world cases brought by participating PCPs. PCPs will review how they can use the I-COPE Program toolkit with each case. Didactic content will include a walkthrough of the PCCDS and education on the demographics of pain and OUD, special considerations for pain management (e.g., cognitive impairment, functional impairment, social determinants, and caregivers), principles of SDM and assessing patient preferences, pharmacology and pain medications, non-pharmacologic pain management options, and recognition and management of OUD. The abridged version of the ECHO training will be made available online for PCPs to access on their own time if needed.

Study Type

Interventional

Enrollment (Actual)

20000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medicine
      • Chicago, Illinois, United States, 60661
        • Access Community Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age over 65 years AND
  • receives care at a participating clinical site AND
  • history of chronic pain AND/OR
  • opioid prescription in the last 28 days AND/OR
  • history of opioid use disorder AND/OR

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: I-COPE Intervention
5 out of the 25 participating primary care sites are randomly assigned to any of the 5 steps. The ICOPE intervention is implemented after a pre interventional period of 3-15 months. The intervention is implemented during 8 weeks. The length of the post interventional period is 11-23 months.
Behavioral: I-COPE
The patient survey will be sent out via MyChart 3 days before the visit. It asks about current pain, goals, treatment history, treatment preferences, and health status. Alternatively, patients will be asked to compete a survey in clinic on paper or a tablet. The surveys will be identical, except screening for screening for depression and opioid use will depend on the availability of previous scores. Survey and the EHR will help auto-generate best practice advisories (BPAs) and a tailored smart set. The smartset is based on AGS and CDC guidelines for chronic pain and opioids. It shows which treatment options are not recommended based on the patient's history, comorbidities, and preferences. The smartset also includes links to decision aid and patient education tools. Personalized action plan will be created with pain rating and goal, treatment plan, and relevant tips and educational materials. Action plan will be clearly laid out using max 6 grade reading level, and simple graphics.
No Intervention: No intervention
Standard of care offered to all patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with high initial pain scores (≥6) who experience a 30% reduction in scores
Time Frame: 6 months
Percentage of patients with high initial pain scores (≥6) who experience a 30% reduction in scores
6 months
Increase diversity of recommended pain treatments
Time Frame: 6 months
More types of treatment are represented in patient's treatment plan. In I-COPE smartset pain treatments are grouped into 4 types: self-management, referrals to specialists, non-opioid medications, and opioid medications.
6 months
Decrease higher-risk pain treatments
Time Frame: 6 months
Discontinuation of opioid/Beer's Criteria medications or decrease in daily milligram equivalents of opioid/Beer's Criteria medications.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain scores among older adults with and without chronic pain diagnoses and high initial pain scores
Time Frame: 6 months
Change in pain scores among older adults with and without chronic pain diagnoses and high initial pain scores
6 months
Increase in guideline concordant opioid prescriptions
Time Frame: 6 months
Increase in naloxone prescribing in patients with >50mg equivalents of opioids or OUD; Increase in the number of annual drug screens in patient with chronic opioid use; Decrease in co-prescribing of opioids and benzodiazepines
6 months
Decrease in percentage of patients prescribed each high-risk treatments
Time Frame: 6 months
High-risk treatments are defined as opioids and Beer's criteria medications
6 months
Increase in percentage of patients prescribed each low-risk treatments
Time Frame: 6 months
Low-risk treatments include all pain treatments except opioids and Beer's criteria medications.
6 months
Percentage of eligible patients who receive an I-COPE action plan
Time Frame: 6 months
Percentage of eligible patients who receive an I-COPE action plan
6 months
Percentage of physicians who use the I-COPE program
Time Frame: 6 months
Percentage of physicians in study sites who use the I-COPE program
6 months
Percentage of clinics who use the I-COPE program
Time Frame: 6 months
Percentage of clinics who successfully implement the I-COPE program
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

Agency for Healthcare Research and Quality (AHRQ)
ACCESS Community Health Network

Investigators

  • Principal Investigator: Mim Ari, MD, University of Chicago
  • Principal Investigator: Neda Laiteerapong, MD, University of Chicago
  • Principal Investigator: Katherine Thompson, MD, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2021

Primary Completion (Actual)

October 31, 2022

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

May 4, 2021

First Submitted That Met QC Criteria

May 4, 2021

First Posted (Actual)

May 7, 2021

Study Record Updates

Last Update Posted (Estimated)

January 19, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB20-1580

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a clinic-level intervention study. Research team will only receive a limited data set with no individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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